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The study included 511 patients who underwent PCI because of angina during 2010-2011 at three Korean hospitals. Clopidogrel-naïve patients received either a loading dose (LD; 600 mg at 2-24 h before the procedure) or routine maintenance therapy (75 mg/day for ≥5 days) plus either a 300-mg reload (RL) or only the maintenance dose (MD).
Elevation of myocardial infarction markers after coronary stenting reflects periprocedural myonecrosis or periprocedural myocardial infarction (PMI), which is associated with an increase in cardiac events and mortality. Thus, we aimed to evaluate various clopidogrel pre-treatment methods for preventing PMI among patients undergoing conventional CAG for stable angina pectoris. The Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina patients (MECCA) study was a prospective, partially randomized, multi-center clinical trial. Between October 2010 and July 2011, 511 patients underwent PCI for angina pectoris at the Korean University Anam Hospital, the Eulji Hospital, and the Hanil General Hospital. Clopidogrel-naïve patients were enrolled to receive a loading dose (the LD group; clopidogrel at 600 mg, usually 2-24 h before the procedure) or routine therapy using daily clopidogrel doses (75 mg/day for ≥5 days). Patients receiving daily doses were randomized to receive either an additional 300-mg reload (the RL group) or no additional loading (the maintenance dose [MD] group). The 600-mg or 75-mg treatment regimens were selected at the physician's discretion. The primary outcome was creatinine kinase myocardial band (CK-MB) levels at several time points. The CK-MB levels were measured at baseline, 8 h, and 24 h, while troponin-I levels were measured at 8 h after the PCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LD group | Active Comparator | clopidogrel 600 mg once loading, usually 2-24 h before the procedure |
|
| MD group | Experimental | After randomization, the routine therapy using daily clopidogrel 75mg |
|
| RL group | Active Comparator | After randomization, additional clopidogrel 300 mg reloading for patients who were taking a maintenance dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clopidogrel 75mg | Drug | clopidogrel once daily 75mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 8hour mean CK-MB | mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI | 8hour after PCI |
| 24hour mean CK-MB | mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI | 24hour after PCI |
| Measure | Description | Time Frame |
|---|---|---|
| 8hour mean troponin-I | mean troponin-I is checked 8hour after PCI | 8hour after PCI |
| Prevalence of periprocedural myocardial infarction (PMI) | Patients were considered to have PMI when their CK-MB level was elevated to >3 times the upper limit of normal, which was defined as 4.94 ng/mL. |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate to severe GUSTO bleeding | Moderate GUSTO bleeding is defined as bleeding that requires blood transfusion but does not result in hemodynamic compromise. severe GUSTO bleeding is defined as a intracranial hemorrhage or hemodynamic compromise requiring treatment. | within 1week after PCI |
Inclusion Criteria:
Written informed consent and, stable angina pectoris and, at least 1 ischemic evidence below
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21670242 | Background | Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available. |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Clopidogrel 300 mg | Drug | clopidogrel 300mg reloading |
|
|
| clopidogrel 600mg | Drug | clopidogrel 600mg loading |
|
|
| 8hour or 24hour after PCI |
| All cause death | All death is evaluated using chart reviews and telephone calls. | 9 months after PCI |
| Coronary revascularization | Coronary revascularization is evaluated using chart reviews and telephone. calls. | 9 months after PCI |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |